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With the FDA facing charges of indifference to the problem of opioid abuse, the agency Thursday recast itself as proactive on the issue, announcing approval of a consumer-friendly new injector that treats opioid overdose. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More
European drug companies and transparency advocates alike are praising the clinical trials legislation advancing through the EU Parliament, with Europe’s largest pharma lobbying group saying the proposal as it now stands will dramatically improve clinical trial efficiency in the EU. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
FDA approval of Stallergene’s under-the-tongue Oralair could be a huge boon for patients who suffer from hay fever and rake in billions more for the drugmaker, whose drug is already available in over two dozen countries. Read More
GlaxoSmithKline has joined a list of drugmakers whose non-small cell lung cancer (NSCLC) drug candidates have failed in Phase III trials in the past year. Read More
With its controversial painkiller Zohydro already banned in Massachusetts and federal lawmakers looking to follow suit, Zogenix has initiated a fierce lobbying campaign to save its flagship product. Read More
Small and medium-sized drugmakers will be able to pay lower — and in some cases, no — fees for certain postauthorization activities under new incentives announced Tuesday by the European Medicines Agency. Read More